Efficacy and Safety of Eleveld PK/PD Model-based Dosing During General Anesthesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Eleveld model-guided dosing, Standard weight-based label dosing.
- Who it may be relevant to
- Registry conditions: Remimazolam, Pharmacokinetics and Pharmacodynamics. Basic parameters: 19 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison of Efficacy and Safety Between Eleveld PK/PD Model-based Dosing and Standard Dosing During General Anesthesia
Overview
The goal of this randomized, controlled clinical trial is to evaluate the efficacy, safety, and recovery profile of an individualized, Eleveld pharmacokinetic/pharmacodynamic model-guided dosing strategy for remimazolam in adult patients undergoing elective non-cardiac surgery under general anesthesia. The main questions it aims to answer are: Does Eleveld model-guided customized dosing significantly reduce the eye-opening time at the end of surgery compared to standard weight-based dosing? Can the Eleveld model-guided approach prevent relative drug accumulation and delayed emergence while maintaining an adequate depth of anesthesia and comparable hemodynamic stability? Researchers will compare the Experimental Group (Eleveld model-guided dosing) to the Control Group (Standard weight-based label dosing) to see if preemptive dose optimization based on individual patient covariates effectively reduces the total drug consumption, frequency of rescue flumazenil administration, and emergence time. Participants will: * Be randomly assigned to receive remimazolam for the induction and maintenance of general anesthesia according to either the Eleveld model-guided customized regimen or the standard weight-based regimen. * Have their depth of anesthesia continuously monitored using a Bispectral Index (BIS) sensor. * Be assessed for the primary outcome (time to eye-opening upon verbal command after discontinuation of anesthetics) and secondary outcomes, including total drug consumption, hemodynamic stability, and postoperative complications (e.g., re-sedation, delirium, PONV).
Interventions
- Drug Eleveld model-guided dosing
Eleveld model-guided dosing via a validated web-based calculator - Drug Standard weight-based label dosing
Induction at 9 mg/kg/h and maintenance at 1-2 mg/kg/h
Primary outcome measures
- Eye-Opening Time, EOT [Time frame: Time from the discontinuation of remimazolam to eye-opening upon verbal command (min), up to 1h]
Secondary outcome measures (12)
- Time to loss of consciousness (LOC) [Time frame: Time from the start of remimazolam administration to loss of consciousness (min), up to 1h]
- Intraoperative Bispectral Index (BIS) values [Time frame: Perioperative/Periprocedural]
- Incidence of intraoperative bradycardia (heart rate < 45 bpm) [Time frame: Perioperative/Periprocedural]
- Incidence of intraoperative tachycardia (heart rate > 110) [Time frame: Perioperative/Periprocedural]
- Incidence of intraoperative hypotension (mean blood pressure < 65 mmHg) [Time frame: Perioperative/Periprocedural]
- Incidence of intraoperative hypertension (SBP > 140 mmHg) [Time frame: Perioperative/Periprocedural]
- Total dose of intraoperative remimazolam (mg) [Time frame: Perioperative/Periprocedural]
- Total dose of intraoperative remifentanil (㎍) [Time frame: Perioperative/Periprocedural]
- Total dose(s) of intraoperative vasopressor(s) [Time frame: Perioperative/Periprocedural]
- Extubation time (min) [Time frame: Time from the discontinuation of remimazolam to the removal of the endotracheal tube, up to 1h]
- Incidence of flumazenil administration [Time frame: From discontinuation of remimazolam to patient discharge from the operating room, up to 1h]
- Incidence of rescue sevoflurane use [Time frame: Perioperative/Periprocedural]
Eligibility criteria
Inclusion criteria
- Patients aged 19 to 79 years undergoing elective non-cardiac surgery expected to last 60 minutes or longer under general anesthesia with endotracheal intubation
Exclusion criteria
- Emergency surgery
- Surgery requiring evoked potential (EP) monitoring
- Chronic benzodiazepine users
- Body Mass Index (BMI) ≥ 35 kg/㎡
- Chronic kidney disease
- Hepatic dysfunction or chronic liver disease
- Contraindication or history of hypersensitivity to remimazolam
- American Society of Anesthesiologists (ASA) physical status ≥ IV
- Pregnant women
- Contraindication or history of hypersensitivity to flumazenil
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT07675850 · 2602-094-1720